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Journal of Regulatory Compliance

The FDCA and Cosmetics Enforcement: Better Late than Never

In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.

How Will Recreational Marijuana Impact Illinois? 

During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.

Regulating the Un-Explainable: The Difficulties in Regulating Artificial Intelligence

From Siri to Alexa, to deep learning algorithms, artificial intelligence (AI) has now become commonplace in most peoples’ lives.  In a business context, AI has become an indispensable tool for businesses to utilize in accomplishing their goals. Due to the complexity of the algorithms required to make quick and complex decisions, a “black box problem” has emerged for those who utilize these increasingly more elaborate forms of AI. The “black box” simply refers to the level of opacity that shrouds the AI decision-making process. While no current regulation explicitly bans or restricts the use of AI in decision making processes, many tech experts argue that the black box of AI needs to be opened in order to deconstruct not only the technically intricate decision-making capabilities of AI, but the possible compliance-related problems this type of technology may cause.

The Future of Online Prescribing

Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies.  The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.

The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades   

It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.

The Tumultuous Regulation and Deregulation of Payday Loans  

Each year, approximately twelve million Americans resort to payday loans for quick money to pay off bills and cover emergency expenses.  The small, short-term unsecured loans give borrowers a quick way to get money with little consideration of their creditworthiness. Borrowers are plagued with extremely high annual percentage rates to offset the seemingly substantial risk to the lender. However, many studies have shown that payday loans carry no more long-term risk to the lender than other forms of credit. Lenders are able to gain from the high interest rates that burden borrowers while simultaneously benefitting from the relatively low-stakes gamble of the nature of the loan. This illuminates a harrowing truth: the real victims of exploitative and predatory “cash advances” are the borrowers themselves who continue taking on more and more of these high-interest loans in a vicious cycle to repay small debts.

Public Health in the Court of Public Opinion: The Pacific Northwest’s Vaccine Crisis

A measles outbreak that has affected 71 people in Washington and4 people in Oregon has ignited public health discourse over vaccinations. Vaccination rates in the Pacific Northwest are among the lowest in the nation. Both Washington and Oregon allow personal belief exemptions from immunizations for school-age children. The outbreak, which continues to spread, may lead Oregon and Washington to follow California’s example of eliminating personal belief exemptions. Eliminating personal belief exemptions, however, may not be the panacea that lawmakers seek. The rise in medical exemptions for vaccines in California indicates the need for a comprehensive vaccination framework.

Charitable Solicitation: Do Threatened Penalties and Sanctions Ever Actually Reach the Non-Profit Organizations Misappropriating Funds?

In order to operate, non-profit organizations rely heavily on the ability to fundraise. The government leaves the regulation of that “charitable solicitation” to individual states, with most requiring formal registration to engage in such activities. With firms vying for organizations’ business to hire consultants to obtain funds, and ethics and oversight firms highlighting the careful approaches that must be utilized to appropriately raise funds for non-profit operations, charitable organizations may find themselves confused and threatened in the space between needing charitable solicitation to survive and maintaining regulatory compliance to engage in the activity itself. While the threats of penalties and sanctions are large and imposing, it appears that few organizations ever face their true weight. Charitable organizations must, of course, comply with each state of registration, but is the fear instilled equal to the reality of the consequences of non-compliance?

The Future of Roe v. Wade

Roe v. Wade has been a controversial Supreme Court decision ever since it was decided in 1973. Critics have tried to overturn it multiple times over the years. Some states have attempted to circumvent the ruling and implement their own abortion laws, while other states have implemented laws to solidify it in the event the decision is overturned. On the 46th anniversary of the opinion, New York passed a new abortion law called the Reproductive Health Act, which has caused an uproar across the country. In addition, this month the Supreme Court ruled to stay on a Louisiana Targeted Regulation of Abortion Providers (“TRAP”) law. The question becomes how will states comply with the ruling of Roe v. Wade when its future seems unknown.